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"SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor "
EU CTIS ID: 2024-516785-12-00
What this study is testing
To study the benefit-risk of SPI-62 in participants with complications due to hypercortisolism related to autolomous cortisol secretion (ACS) in patients managed under standard of care
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •Adult participants able to give informed consent and willing to adhere to necessary reproductive precautions.
- •Participants with benign adrenal lesions(s) with proven ACS (clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines).
- • Participants should have documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, osteopenia, attributable to clinically significant hypercortisolism.
- • Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical or medical therapy(ies) approved in their region of residence.
You likely can't join if
- • Participants with adrenal Cushing’s syndrome (aCs) will be excluded.
- • Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
- • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.
- • History of adrenalectomy or planned adrenalectomy within 4 months after enrollment.
- • Hypercortisolism which is exogenous including ACTH-dependent, cyclical, intermittent, or physiological (a.k.a. pseudo-Cushing’s).
- • Participants who plan to undergo curative adrenal surgery within the next 3 years.
See the full eligibility criteria
- •Adult participants able to give informed consent and willing to adhere to necessary reproductive precautions.
- •Participants with benign adrenal lesions(s) with proven ACS (clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines).
- • Participants should have documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, osteopenia, attributable to clinically significant hypercortisolism.
- • Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical or medical therapy(ies) approved in their region of residence.
- • Participants with adrenal Cushing’s syndrome (aCs) will be excluded.
- • Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
- • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.
- • History of adrenalectomy or planned adrenalectomy within 4 months after enrollment.
- • Hypercortisolism which is exogenous including ACTH-dependent, cyclical, intermittent, or physiological (a.k.a. pseudo-Cushing’s).
- • Participants who plan to undergo curative adrenal surgery within the next 3 years.
- • History of idiopathic thrombocytopenia.
- • History of cancer within 3 years likely to require further testing or intervention during the trial period or associate with a poor prognosis (e.g., other than treatable skin, thyroid, or early-stage prostate cancer, please consult with Medical Monitor for others).
- • Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
- • Pregnant or lactating.
- • Other medical contraindications to SPI-62 therapy or other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.